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Concomitant Medication

1 Formulär  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Phase type
Beskrivning

Phase type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C0332307
Concomitant Medication
Beskrivning

Concomitant Medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
Have any medications/treatments been administered during the timeframe specified in the protocol?
Beskrivning

All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of each dose of study vaccine and ending 21 days after each dose of study vaccine are to be recorded with generic name of the medication (trade names are allowed for combination drugs, i.e., multi-component drugs), medical indication, total daily dose, route of administration, start and end dates of treatment. Any treatments and/or medications specifically contraindicated, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered within three months preceding the vaccination or at any time during the study period are to be recorded with generic name of the medication (trade names are allowed for combination drugs only), medical indication, total daily dose, route of administration, start and end dates of treatment. Any investigational medication administered throughout the study (i.e., from Visit "Day 0" through Visit "Day 42") must be recorded in the eCRF. (PROTOCOL VIOLATION)

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Trade / Generic Name of vaccine
Beskrivning

Trade / Generic Name of vaccine

Datatyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013227
Medical indication of concomitant medication
Beskrivning

A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g., an anti-pyretic is considered to be prophylactic when it is given in the absence of fever and any other symptom, to prevent fever from occurring). Given that an important goal of this protocol is to study the relative tolerability of various regimens, the use of prophylactic medications to prevent or pre-empt symptoms due to vaccination is specifically prohibited.

Datatyp

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Of other medical indication of concomitant medication, please specify
Beskrivning

Other medical indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Total daily dose
Beskrivning

Total daily dose

Datatyp

text

Alias
UMLS CUI [1]
C2826638
Route of medication administration
Beskrivning

Route of medication administration

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Start date of concomitant medication
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C2826734
End date of concomitant medication
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C2826744
Tick if concomitant medication continuing after "Day 42"
Beskrivning

Concomitant medication, continious

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Comment for GSK
Beskrivning

Comment for GSK

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
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Similar models

Concomitant Medication

1 Formulär
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Phase type
integer
C0205390 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Phase type
CL Item
active phase (1)
CL Item
after telephone contact (2)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Item
Have any medications/treatments been administered during the timeframe specified in the protocol?
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant vaccination
Code List
Have any medications/treatments been administered during the timeframe specified in the protocol?
CL Item
No (N)
CL Item
Yes (Y)
Trade / Generic Name of vaccine
Item
Trade / Generic Name of vaccine
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Medical indication of concomitant medication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical indication
Code List
Medical indication of concomitant medication
CL Item
Prophylactic (1)
Other medical indication
Item
Of other medical indication of concomitant medication, please specify
text
C0205394 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Total daily dose
Item
Total daily dose
text
C2826638 (UMLS CUI [1])
Item
Route of medication administration
text
C0013153 (UMLS CUI [1])
Route of vaccine administration
Code List
Route of medication administration
CL Item
Intradermal (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation (IH)
CL Item
Oral (PO)
CL Item
Intramuscular (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal (NA)
CL Item
Transdermal (TD)
CL Item
Other (OTH)
CL Item
Unknown (UNK)
CL Item
External (EXT)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Rectal (PR)
CL Item
Topical (TO)
CL Item
Vaginal (VA)
Start date of concomitant medication
Item
Start date of concomitant medication
date
C2826734 (UMLS CUI [1])
End date of concomitant medication
Item
End date of concomitant medication
date
C2826744 (UMLS CUI [1])
Concomitant medication, continious
Item
Tick if concomitant medication continuing after "Day 42"
boolean
C2826666 (UMLS CUI [1])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
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